RT Journal Article
SR Electronic
T1 Bosentan in Clinical Practice for Treating Digital and Other Ischemic Ulcers in Spanish Patients with Systemic Sclerosis: IBER-DU Cohort Study
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.101266
DO 10.3899/jrheum.101266
A1 José Andrés Roman Ivorra
A1 Carmen Pilar Simeon
A1 Juan José Alegre Sancho
A1 Maria Victoria Egurbide
A1 Maria Jesús Castillo
A1 Xavier Lloria
A1 Vicent Fonollosa
YR 2011
UL http://www.jrheum.org/content/early/2011/05/30/jrheum.101266.abstract
AB Objective To describe treatment outcomes and safety experience with bosentan in patients with systemic sclerosis (SSc) and digital ulcers (DU), in a clinical setting in Spain. Methods This was a multicenter, noninterventional retrospective cohort study. Data were collected retrospectively from patients with DU, with or without pulmonary arterial hypertension (PAH), who were initiating bosentan therapy in 2003 (n = 26) or 2004 (n = 41) and followed until May 2005. Data were obtained from centers prescribing bosentan. Relevant measures included number of DU, occurrence of new DU, overall DU clinical status (improved, stabilized, worsened), and bosentan-associated adverse events. Results Sixty-seven patients with SSc and DU or other ulcers were included. PAH was also present in 12 patients (18%). At the start of bosentan treatment, the median number of DU per patient was 3.0. The median change in number of DU was –3.6 and –5.0 at 12 and 24 months, respectively. Sixty-eight percent of the patients did not develop any new DU at 12 months. DU clinical status was reported at 12 months for 22 patients: 18 patients (81.8%) improved and 4 (18.2%) stabilized. The median treatment duration was 13.0 months. The main adverse event was increase of aminotransferase, observed in 5 patients (7%), leading to discontinuation of treatment in 3 patients (4.4%). Conclusion Previously reported results of bosentan efficacy in DU management are reproducible in clinical practice. This efficacy is maintained in the longterm followup. Bosentan treatment was well tolerated and adverse events were comparable with those observed in previous reports.